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FDA clearance

Medical Devices & Diagnostics

Can Cataltheia’s Deseyne lens replace multifocal optics in age-related vision correction?

FDA clears Deseyne, the first EDOF contact lens for presbyopia. Find out how it could reshape non-surgical vision correction in the U.S. market.

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Medical Devices & Diagnostics

Will Biobeat’s wearable BP patch become the new standard in hypertension diagnosis?

Biobeat raises $50M to commercialize its FDA-cleared patch-worn ABPM system. Find out how this device could change hypertension care in the U.S.

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Medical Devices & Diagnostics

What the Bendit17 microcatheter FDA clearance signals for catheter innovation

Bendit Technologies has secured 510(k) clearance from the U.S. Food and Drug Administration for its Bendit17 steerable microcatheter, a device the company describes as the smallest steerable microcatheter available for use in neurovascular and peripheral endovascular interventions. With U.S. commercialization slated to begin in January 2026, the Israel-based medical device manufacturer is also pursuing regulatory

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Pharma & Biotech

What Neurizon’s entry into the HEALEY ALS trial means for the future of NUZ-001

Neurizon Therapeutics Limited has received clearance from the United States Food and Drug Administration for its investigational therapy NUZ-001 to be included in the HEALEY ALS Platform Trial, a globally recognized adaptive trial framework for amyotrophic lateral sclerosis. The decision formally designates NUZ-001 as Regimen I in the platform, allowing clinical site activation and study

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Medical Devices & Diagnostics

How Medtronic’s surgical robotics push could reshape operating rooms nationwide

Medtronic’s Hugo robot gets FDA clearance for urology. Explore how it could reshape U.S. robotic surgery and challenge incumbent systems like da Vinci.

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